I’ve been writing about (and against) medical ghostwriting since I first learned about this Big Pharma marketing practice. In fact, my gobsmacked reaction to this very subject is largely why the Ethical Nag site was launched in the first place. I had just learned about lawsuits* filed in the U.S. by thousands of women diagnosed with breast cancer – a diagnosis suspiciously linked to their hormone replacement therapy (HRT). And recently the journal Public Library of Science Medicine (who with the New York Times originally broke the story) published an unprecedented analysis of the issue that caused the link.

The poster child of medical ghostwriting is Wyeth Pharmaceuticals Inc. (now owned by Pfizer, the world’s biggest drug company) who were then the makers of the best-selling HRT drugs on earth, Premarin and Prempro.

Wyeth’s ghostwritten medical journal articles attempted to:

• mitigate the perceived risks of breast cancer associated with HRT
• defend the unsupported cardiovascular “benefits” of HRT
• promote off-label, unproven uses of HRT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.

But first, what exactly is medical ghostwriting? And why is it so bad?  

From a basic PR perspective, I look at how the pharmaceutical companies might see the practice, (from Partners In Slime: Why You Should Be Alarmed About Medical Ghostwriting):

“You pay for dozens of favourable medical journal articles about your drugs that claim, fraudulently, to be authored by noted researchers instead of your own hired  ghostwriters. Other doctors out there then read these published journal articles, and are duly convinced to start prescribing more of your drugs to their patients. Your drug company makes lots of money. You get a big bonus at the end of the year. The academics get to claim authorship of yet another journal publication for their CVs.

“Everybody wins. Except for us patients.”

Dr. Adriane Fugh-Berman of the Georgetown University Medical Center in Washington has examined 1,500 internal Wyeth documents. She explained how the drugmaker hired a medical communications company called DesignWrite to co-ordinate its ghostwriting strategy to help push Premarin and Prempro.

The Wyeth ghostwriting practices that Dr. Fugh-Berman documents in her latest PLoS Medicine article include:

• the drugmaker’s strategies around publication planning
• recruiting academics to pose as the article authors so medical journals would accept their submissions
• inserting marketing messages into journal articles including the promotion of off-label, unproved uses of HRT (such as prevention of dementia, Parkinson’s disease, and visual impairment)
• overstating the benefits of the drugs
• downplaying harms including the risk of breast cancer, which was beginning to be recognised
• defending a cardiovascular benefit despite no evidence

Documents revealed DesignWrite created over 50 peer-reviewed articles and over 50 scientific abstracts and posters, journal supplements, internal white papers and slide kits between 1997 and 2003. These were then falsely attributed to well-known academic “authors” and used to promote unproven benefits and downplay harms of Wyeth’s menopausal hormone therapy and to cast competing therapies in a negative light.

Dr. Peter Byass of the Umeå Centre for Global Health Research in Sweden added this interesting perspective in PLoS Medicine this week:

“The underlying assumption here – that senior researchers don’t write their own papers anyway, but rely on their post-doctoral students – is even worse than the ghostwriting saga itself. If it is really true that some senior researchers don’t do a lot of their own research, analysis and writing, perhaps we shouldn’t be too surprised that opportunities for ghostwriting have occurred.”

In other words, medical school academics may already be used to their young students doing the actual work for them and then just signing off their scientific papers as “guest” authors, so getting into bed with industry-funded ghostwriters may seem like no big deal.

Alarmingly, Dr. Fugh-Berman reported this week that many doctors still prescribe HRT to all their menopausal patients to prevent heart disease, despite overwhelming evidence of its danger. She wrote in her investigation:

“This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.”

Meanwhile, industry-funded articles that make their way into medical journals are very profitable for the journals themselves. The New England Journal of Medicine, for example, sold 929,400 reprints of a single research article they had published about the now-discredited painkiller Vioxx (most of these reprints were actually sold to the drug’s manufacturer Merck to distribute to physicians as part of their Vioxx sales pitch) bringing in more than $697,000 in revenue for the NEJM.

Find out more in Dr. Adriane Fugh-Berman’s September 7, 2010 article from the journal Public Library of Science Medicine.

See also:

• Partners In Slime: Why You Should Be Alarmed About Medical Ghostwriting
• Medical Ghostwriting: If You’re Not Alarmed, Maybe You’re Just Not Paying Attention
• Medical Ghostwriting and Guest Authorship: Twins Separated At Birth?
• What If Everybody Just Started Telling the Truth About Medical Ghostwriting?
  

NEWS UPDATE: June 19, 2012

Pfizer Paid $896 Million in Prempro Settlements

Pfizer, the world’s largest drugmaker, has now settled about 6,000 lawsuits alleging Prempro and other hormone-replacement drugs caused breast cancer, and has set aside an additional $330 million to resolve the remaining 4,000 suits, according to a May 10, 2012 filing with the U.S. Securities and Exchange Commission. The reserve means New York-based Pfizer has now committed more than $1.2 billion to resolving claims that it failed to properly warn women about the menopause drugs’ health risk.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. These hormone medications are still on the market.

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